Download A&D UA-767PBT-C blood pressure unit

Transcript
Digital Blood Pressure Monitor
Model UA-767
BT-C
Instruction Manual
Original
Manuel d’instructions
Traduction
Manual de Instrucciones
Traducción
Manuale di Istruzioni
Traduzione
Bedienungsanleitung
Übersetzung
Gebruiksaanwijzing
Vertaling
使用手冊
1WMPD4002093C
翻譯
Contents
Dear Customers .......................................................................2
Preliminary Remarks.................................................................2
Precautions ..............................................................................2
Contraindications ................................................................3
Parts Identification ...................................................................4
Symbols ...................................................................................5
Using The Monitor....................................................................6
Installing / Changing The Batteries ......................................6
Connecting The Air Hose .....................................................6
Connecting The AC Adapter .................................................7
Pairing The PBT-C Series Device With A Continua Manager...7
Selecting The Correct Cuff Size ............................................8
Applying The Arm Cuff ........................................................9
How To Take Proper Measurements .......................................9
Measurement.......................................................................9
After Measurement ..............................................................9
Measurements........................................................................10
Normal Measurement.........................................................10
Measurement With The Desired Systolic Pressure ...............11
Notes For Proper Measurement ..........................................11
What Is An Irregular Heartbeat................................................12
Pressure Bar Indicator.............................................................12
Transmitting Data To A Continua Manager .............................12
About Blood Pressure .............................................................13
What Is Blood Pressure? .....................................................13
What Is Hypertension And How Is It Controlled? .................13
Why Measure Blood Pressure At Home? ..............................13
WHO Blood Pressure Classification .....................................13
Blood Pressure Variations...................................................13
Troubleshooting.....................................................................14
Maintenance...........................................................................15
Technical Data........................................................................15
English 1
Dear Customers
Congratulations on purchasing a state-of-the-art A&D blood pressure
monitor, one of the most advanced monitors available today. Designed
for ease of use and accuracy, this monitor will facilitate your daily blood
pressure regimen.
We recommend that you read through this manual carefully before
using the device for the first time.
Preliminary Remarks
This device conforms to the European Directive 93/42 EEC for Medical
mark of conformity.
Products. This is made evident by the
(0123: The reference number to the involved notified body)
The WML-40AH is approved in accordance to R&TTE directive
, manufactured by MITSUMI
transmitter module marked by
incorporated to OEM product.
The device complies with part 15 of the FCC rules and contains the FCC
ID POOWML-C40.
Compliance with Industry Canada.
IC: 4250A-WMLC40.
The device is a Continua certified, Bluetooth wireless technology
enabled medical device.
The device is designed for use on adults only, not newborns or infants.
Environment for use
The device is for use in the home healthcare environment.
This device is designed to measure blood pressure and pulse rate of people
for diagnosis.
Precautions
Precision components are used in the construction of this device.
Extremes in temperature, humidity, direct sunlight, shock or dust should
be avoided.
Clean the device and cuff with a dry, soft cloth or a cloth dampened with
water and a neutral detergent. Never use alcohol, benzene, thinner or
other harsh chemicals to clean the device or cuff.
Avoid tightly folding the cuff or storing the hose tightly twisted for long
periods, as such treatment may shorten the life of the components.
The device and cuff are not water resistant. Prevent rain, sweat and
water from soiling the device and cuff.
Measurements may be distorted if the device is used close to televisions,
microwave ovens, cellular telephones, X-ray or other devices with strong
electrical fields.
English 2
Used equipment, parts and batteries are not treated as ordinary
household waste, and must be disposed of according to the applicable
local regulations.
When the AC adapter is used, make sure that the AC adapter can be
readily removed from the electrical outlet when necessary.
When reusing the device, confirm that the device is clean.
Do not modify the device. It may cause accidents or damage to the device.
To measure blood pressure, the arm must be squeezed by the cuff hard
enough to temporarily stop blood flow through the artery. This may cause
pain, numbness or a temporary red mark to the arm. This condition will
appear especially when measurement is repeated successively.
Any pain, numbness, or red marks will disappear with time.
Contraindications
The following are precautions for proper use of the device.
Do not apply the cuff to an arm with another medical electrical equipment
attached. The equipment may not function properly.
People who have a severe circulatory deficit in the arm must consult a
doctor before using the device, to avoid medical problems.
Do not self-diagnose the measurement results and start treatment by yourself.
Always consult your doctor for evaluation of the results and treatment.
Do not apply the cuff on an arm with an unhealed wound.
Do not apply the cuff on an arm receiving an intravenous drip or blood
transfusion. It may cause injury or accidents.
Do not use the device where flammable gases such as anesthetic gases
are present. It may cause an explosion.
Do not use the device in highly concentrated oxygen environments, such as a
high-pressure oxygen chamber or an oxygen tent. It may cause a fire or explosion.
English 3
Parts Identification
DC Jack
START Button
Display
Air Connector Plug
Air Socket
Air Hose
Proper Fit Range
Artery Position Mark
Index Mark
Battery Cover
Arm Cuff
Battery Compartment
1.5V Batteries
(LR6, R6P or AA)
Part of Display
MEMORY
Systolic Pressure
Diastolic Pressure
Pressure Bar Indicator
Pulse Rate
Battery Indicator
I.H.B. Indicator (Irregular heartbeat indicator)
English 4
Heart Mark
Symbols
Symbols
Function / Meaning
Standby and power on.
Battery installation guide
Direct current
Type BF: Device, cuff and tubing are
designed to provide special protection
against electrical shocks.
The indicator that appears while
measurement is in progress. It blinks
when the pulse is detected.
Irregular Heartbeat indicator. (I.H.B.)
The indicator that appears when an
irregular heartbeat or any excessive
body movement is detected during the
measurement.
Previous measurements stored in
MEMORY.
The battery power indicator during the
Full Battery measurement.
The indicator blinks when battery power
Low Battery is low.
Unstable blood pressure due to
movement during the measurement.
The systolic and diastolic values are
within 10 mmHg of each other.
The pressure value did not increase
during inflation.
The cuff is not fastened correctly.
PUL. DISPLAY ERROR
SYS
DIA
PUL./min
The pulse is not detected correctly.
Systolic blood pressure in mmHg
Diastolic blood pressure in mmHg.
Pulse per minute
EC directive medical device label
R&TTE directive transmitter module label
Manufacturer
EC
REP
EU-representative
Date of manufacture
Class II device
WEEE label
English 5
Recommended Action
Measurement is in
progress. Remain as still as
possible.
Replace all batteries with
new ones, when the
indicator blinks.
Try the measurement
again. Remain very still
during the measurement.
Fasten the cuff correctly,
and try the measurement
again.
Symbols
Function / Meaning
Recommended Action
Refer to instruction manual/booklet
SN
Serial number
Polarity of DC jack
Using The Monitor
Installing / Changing The Batteries
Step 1
1.
Slide the battery cover up to open it.
2.
Remove the used batteries and insert
new batteries into the battery
compartment as shown, taking care that
the polarities (+) and (-) are correct.
3.
Step 3
Step 2
Slide the battery cover down to close.
Use only LR6, R6P or AA batteries.
CAUTION
Insert the batteries as shown in the battery compartment. If not, the
device will not work.
When
(LOW BATTERY mark) blinks in the display, replace all batteries
with new ones. Do not mix old and new batteries. It may shorten the
battery life, or cause the device to malfunction.
(LOW BATTERY mark) does not appear when the batteries are drained.
Battery life varies with the ambient temperature and may be shorter at
low temperatures.
Remove the batteries if the device is not to be used for a long time.
The batteries may leak and cause a malfunction.
Use the specified batteries only. The batteries provided with the device
are for testing monitor performance and may have a limited life.
Connecting The Air Hose
Air Hose
Insert the air connector plug into
the air socket firmly.
Air Connector Plug
Air Socket
English 6
Using The Monitor
Connecting The AC Adapter
Insert the AC adapter plug into the
DC jack.
Next, connect the AC adapter to
an electrical outlet.
Use the specified AC adapter.
(Refer to page 16.)
DC jack
AC adapter plug
Pairing The PBT-C Series Device With A Continua-Compliant
Manager
Model UA-767
BT-C is a PBT-C series device. PBT-C series devices are
designed to be connected only with Continua Managers.
To pair the device with a Manager, please follow these steps:
1.
Remove the four batteries from the device.
2.
Press the START button several times to discharge the device
completely.
3.
Insert the four batteries into the device.
4.
Refer to the Manager’s instruction manual to start a Bluetooth discovery
and inquiry process.
The device will stay discoverable for 60 seconds.
If the Manager fails to pair with the device, repeat steps 1 through 3.
5.
Once the Manager has discovered the device, enter the PIN “123456” as
a password to finish the pairing process.
When the Manager supports SSP (Secure Simple Pairing), no password
is required for the pairing process.
A device that has been certified by Continua
displays this logo.
A Bluetooth device has the logo mark of Bluetooth
printed on it.
English 7
Using The Monitor
Selecting The Correct Cuff Size
Using the correct cuff size is important for an accurate reading. If the cuff is not
the proper size, the reading may yield an incorrect blood pressure value.
The arm size is printed on each cuff.
The index
and proper fit range, on the cuff, tell you if you are applying the
correct cuff. (Refer to "Symbols that are printed on the cuff".)
If the index
points outside of the range, contact your local dealer to purchase a
replacement cuff.
The arm cuff is a consumable. If it becomes worn, purchase a new one.
Arm Size
Recommended Cuff Size
32 cm to 45 cm
Large adult cuff
22 cm to 32 cm
Adult cuff
Arm size: The circumference of the biceps.
Note: Model UA-767
BT-C is not designed for using a small adult cuff.
Symbols that are printed on the cuff
Symbols
Function/Meaning
Recommended Action
mark on the artery of
Set the
the upper arm or in line with the
ring finger on the inside of the arm.
Artery position mark
▲
REF
Catalog Number
CUF-D-LA
CUF-D-A
Index
Catalog number
Proper fit range for the adult cuff.
It's printed on the adult cuff.
Range to use the large adult cuff.
Over range printed on the adult cuff.
Proper fit range for the large adult cuff.
It's printed on the large adult cuff.
Under range printed on the adult cuff.
Range to use the adult cuff.
It's printed on the large adult cuff.
Use the large adult cuff instead of
the adult cuff.
Use the adult cuff instead of the
large adult cuff.
Lot number
Proper fit range
Large adult cuff
Proper fit range
Adult cuff
English 8
Using The Monitor
Applying The Arm Cuff
1. Wrap the cuff around the upper arm,
about 1-2 cm above the inside of
the elbow, as shown.
Place the cuff directly against the
skin, as clothing may cause a faint
pulse, and result in a measurement
error.
Do not roll up shirtsleeve tightly
Cuff
Artery position mark
2. Constriction of the upper arm,
caused by tightly rolling up a
shirtsleeve, may prevent accurate
readings.
3. Confirm that the index
within the proper fit range.
1 to 2 cm
Secure the fabric
fastener firmly
Air hose
points
Index
and Proper fit range
How To Take Proper Measurements
For the most accurate blood
pressure measurement:
Sit comfortably on a chair. Rest your arm on the table. Do not cross your
legs. Keep your feet on the floor and straighten your back.
Relax for about five to ten minutes before measurement.
Place the center of the cuff at the same height as your heart.
Remain still and keep quiet during measurement.
Do not measure immediately after physical exercise or a bath. Rest for
twenty or thirty minutes before taking the measurement.
Try to measure your blood pressure at the same time every day.
Measurement
During measurement, it is normal for the cuff to feel very tight. (Do not be
alarmed)
After Measurement
After measurement, press the START
Remove the cuff and record your data.
button to turn off the power.
Note: The device has an automatic power shut-off function, which turns the
power off approximately one minute after measurement.
Allow at least three minutes between measurements on the same person.
English 9
Measurements
Model UA-767
BT-C is designed to detect the pulse and to inflate
the cuff to a systolic pressure level automatically.
If your systolic pressure is expected to exceed 230 mmHg or you use the
optional small cuff, read "Measurement with the desired systolic
pressure" on the next page.
Normal Measurement
1.
Place the cuff on the arm (preferably the left arm).
At heart level
Sit quietly during measurement.
2.
Press the START button.
The last data of systolic and diastolic
pressure and pulse rate are displayed
briefly. Then the display changes, as
indicated in the figure at the right, as the
measurement begins. The cuff starts to
inflate. It is normal for the cuff to feel very
tight. A pressure bar indicator is displayed,
as in the figure at the right, during inflation.
Note: If you wish to stop inflation at any time,
press the START button again.
3.
When inflation is complete, deflation starts
automatically and the
(heart mark)
blinks, indicating that the measurement is
in progress. Once the pulse is detected,
the mark blinks with each pulse beat.
Note: If an appropriate pressure is not
obtained, the device starts to inflate
again automatically.
4.
5.
When the measurement is complete, the
systolic and diastolic pressure readings and
pulse rate are displayed. The cuff exhausts
the remaining air and deflates completely.
Press the START
off the power.
button again to turn
START button
The last data
at initial display
Starts inflation
Pressurizing
Measurement
in progress
Systolic pressure
Diastolic pressure
Pulse rate
Exhausts remaining
air automatically
Note: Model UA-767
BT-C is provided with an automatic power
shut-off function. Allow at least three minutes between
measurements on the same person.
English 10
Measurements
Measurement With The Desired Systolic Pressure
If your systolic pressure is expected to exceed 230 mmHg or you use the
optional small cuff, use this procedure.
1.
Place the cuff on the arm (preferably the left arm).
2.
Press and hold the START button
until a number about 30 to 40 mmHg
higher than your expected systolic
pressure appears.
3.
Release the START button to start
measurement, when the desired
number is reached. Then continue to
measure your blood pressure as
described on the previous page.
At heart level
Press and hold the button
Release the button
at the desired
systolic pressure
Refer to the previous page
for measurement
Notes For Proper Measurement
Sit down in a comfortable position. Place the arm to be used for the
measurement on a table or other support so that the center of the cuff
will be at the same height as your heart.
Relax for about five or ten minutes before taking a measurement. If you
are excited or depressed by emotional stress, the measurement will
reflect this stress as a higher (or lower) than normal blood pressure
reading and the pulse reading will usually be faster than normal.
An individual's blood pressure varies constantly, depending on what you
are doing and what you have eaten. What you drink can have a very
strong and rapid effect on your blood pressure.
This device bases its measurements on the heartbeat. If you have a very
weak or irregular heartbeat, the device may have difficulty determining
your blood pressure.
Should the device detect a condition that is abnormal, it will stop the
measurement and display an error symbol. See page 5 for the
description of symbols.
This blood pressure monitor is intended for use by adults only. Consult
with your physician before using this device on a child. A child should not
use this device unattended.
English 11
What Is An Irregular Heartbeat
Model UA-767
BT-C blood pressure monitor provides a blood
pressure and pulse rate measurement even when an irregular heartbeat
occurs. An irregular heartbeat is defined as a heartbeat that varies by
25% from the average of all heartbeats during the blood pressure
measurement. It is important that you be relaxed, remain still and do not
talk during measurements.
Note: We recommend contacting your physician if you see this
indicator frequently.
Pressure Bar Indicator
The indicator monitors the progress of pressure during measurement.
Pressurizing
Inflation in progress
Releasing air
Measurement in progress
Inflation complete
Transmitting Data To A Continua Manager
Measurement results will be automatically transmitted to the paired
Manager at each measurement. In the case of unsuccessful
transmission, the device stores the last 25 measurements in memory.
The device will send all of the data at the next successful connection and
clear memory.
English 12
About Blood Pressure
What Is Blood Pressure?
Blood pressure is the force exerted by blood against the walls of the arteries.
Systolic pressure occurs when the heart contracts. Diastolic pressure occurs
when the heart expands. Blood pressure is measured in millimeters of
mercury (mmHg). One's natural blood pressure is represented by the
fundamental pressure, which is measured first thing in the morning while one
is still at rest and before eating.
What Is Hypertension And How Is It Controlled?
Hypertension, an abnormally high arterial blood pressure, if left unattended,
can cause many health problems including stroke and heart attack.
Hypertension can be controlled by altering lifestyle, avoiding stress, and with
medication under a doctor’s supervision.
To prevent hypertension or keep it under control:
Do not smoke
Exercise regularly
Reduce salt and fat intake
Have regular physical checkups
Maintain proper weight
Why Measure Blood Pressure At Home?
Blood pressure measured at a clinic or doctor's office may cause
apprehension and can produce an elevated reading, 25 to 30 mmHg higher
than that measured at home. Home measurement reduces the effects of
outside influences on blood pressure readings, supplements the doctor's
readings and provides a more accurate, complete blood pressure history.
WHO Blood Pressure Classification
Blood Pressure Variations
Diastolic blood pressure
Standards to assess high Reference Material: Journal of Hypertension 1999, Vol 17 No.2
blood
pressure,
without mmHg
Grade 3 hypertension (severe)
110
regard to age, have been
Grade 2 hypertension (moderate)
105
established by the World
100
Health Organization (WHO),
Grade 1 hypertension (mild)
95
as shown in the chart.
90
85
80
High-normal
Normal
Optimal
An individual’s blood pressure
120 130 140 150 160 170 180
varies greatly on a daily and
Systolic blood pressure
mmHg
seasonal basis. It may vary by
30 to 50 mmHg due to various conditions during the day. In hypertensive
individuals’ variations are even more pronounced. Normally, the blood
pressure rises while at work or play and falls to its lowest levels during sleep.
So, do not be overly concerned by the results of one measurement.
Take measurements at the same time every day using the procedure
English 13
Typical fluctuation within a day
(Measured every five minutes)
Systolic
Blood pressure
described in this manual to get to know your
normal blood pressure. Regular readings give
a more comprehensive blood pressure history.
Be sure to note date and time when recording
your blood pressure. Consult your doctor to
interpret your blood pressure data.
Sleep
Diastolic
PM
AM
Time
Troubleshooting
Problem
Possible Reason
Nothing appears Batteries are drained.
in the display,
even when the
Battery terminals are not
power is turned in the correct position.
on.
Battery power is low.
(LOW BATTERY
The cuff does
mark) blinks. [ If the
not inflate.
batteries are drained
completely, the mark
does not appear.]
The cuff is not applied
properly.
You moved your arm or
body during the
The unit does
measurement.
not measure.
Readings are
The cuff position is not
too high or too
correct.
low.
Recommended Action
Replace all batteries with new ones.
Reinstall the batteries with
negative and positive terminals
matching those indicated on the
battery compartment.
Replace all batteries with new
ones.
Apply the cuff correctly.
Make sure you remain very still
and quiet during the
measurement.
Sit comfortably and still.
Raise your hand so that the cuff is
at the same level as your heart.
If you have a very weak or
irregular heat beat, the device may
have difficulty in determining your
blood pressure.
The value is different
See “Why measure blood
from that measured at a
pressure at home”.
clinic or doctor’s office.
Other
Remove the batteries. Place them
back properly and try the
measurement again.
Note: If the actions described above do not solve the problem, contact the
dealer. Do not attempt to open or repair this product, as any attempt to do
so will make your warranty invalid.
English 14
Maintenance
Do not open the device. It uses delicate electrical components and an
intricate air unit that could be damaged. If you cannot fix the problem
using the troubleshooting instructions, request service from your dealer
or from the A&D service group. The A&D service group will provide
technical information, spare parts and units to authorized dealers.
The device was designed and manufactured for a long service life.
However it is generally recommended to have the device inspected
every 2 years, to ensure proper functioning and accuracy. This
maintenance recommendation is for European customers only, to comply
with regulatory requirements. Routine inspection and maintenance is not
needed for non-European customers. Please contact either your
authorized dealer or A&D for maintenance.
Technical Data
Type
Measurement method
Measurement range
UA-767PBT-C
Oscillometric measurement
Pressure: 20 - 280 mmHg
Pulse:
40 - 200 beats / minute
Measurement accuracy
Pressure: ±3 mmHg
Pulse:
±5%
Power supply
4 x 1.5V batteries (LR6, R6P or AA) or
AC adapter (TB-233) (Not included)
Number of measurements
Approx. 450 measurements, when AA Alkaline
batteries are used, with pressure value of 180
mmHg at room temperature of 23°C
Classification
Internally powered ME equipment (Supplied by
batteries) /
Class II (Supplied by adapter)
Continuous operation mode
Clinical test
According to ANSI / AAMI SP-10 1987
EMC
IEC 60601-1-2: 2007
Wireless communication WML-40AH (MITSUMI Electronics Co. Ltd.)
Bluetooth Ver.2.1 Class 1 HDP
Continua certified
Operating conditions
+10°C to +40°C / 15%RH to 85 %RH
800 hPa to 1060 hPa
Transport / Storage conditions -10°C to +60°C / 15%RH to 85 %RH
Dimensions
Approx. 147 [W] x 64 [H] x 110 [D] mm
Weight
Approx. 300 g, excepting batteries
Applied part
Cuff Type BF
English 15
Useful life
Accessory AC adapter
TB-233
TB-233C
Device: 5 years (when used six times a day)
Cuff: 2 years (when used six times a day)
The adapter is to connect the blood pressure
monitor to a power source at home.
Please contact your local A&D dealer for
purchasing.
The AC adapter is required to be inspected or
replaced periodically.
Input: 100-240V
Output: 6V
500mA
139°C
TB-233BF
2A
Input: 100-240V
500mA
Output: 6V
139°C
2A
Accessories sold separately
Cuff
Arm Size
Catalog Number
Cuff Size
CUF-D-LA
Large adult cuff 32 cm to 45 cm
CUF-D-A
Adult cuff
22 cm to 32 cm
AC adapter
Catalog Number
Plug
TB-233C
Type C
TB-233BF
Type BF
Note: Specifications are subject to change for improvement without prior notice.
EMC table information is listed on our website:
http://www.aandd.jp/products/manual/medical/emc_acadapter_en.pdf
English 16
1-243 Asahi, Kitamoto-shi, Saitama 364-8585 JAPAN
Telephone: [81] (48) 593-1111
Fax: [81] (48) 593-1119
A&D INSTRUMENTS LIMITED
Unit 24/26 Blacklands Way, Abingdon Business Park, Abingdon, Oxfordshire OX14 1DY United Kingdom
Telephone: [44] (1235) 550420
Fax: [44] (1235) 550485
A&D ENGINEERING, INC.
1756 Automation Parkway, San Jose, California 95131 U.S.A.
Telephone: [1] (408) 263-5333
Fax: [1] (408)263-0119
A&D AUSTRALASIA PTY LTD
32 Dew Street, Thebarton, South Australia 5031 AUSTRALIA
Telephone: [61] (8) 8301-8100
Fax: [61] (8) 8352-7409